Evaluating STP0404 for treating HIV-1 in adults
A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Adults With HIV-1 Infection
This study is testing a new medication called STP0404 to see if it can safely help adults with HIV-1 who haven't had much treatment before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | ST Pharm Co., Ltd. Industry-sponsored |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT05869643 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the antiviral effects, safety, tolerability, and pharmacokinetics of STP0404, a medication for adults living with HIV-1 infection. Participants will receive varying doses of STP0404 or a placebo to determine the most effective and safe dosage. The study focuses on treatment-naïve individuals or those with limited prior treatment history, ensuring a clear evaluation of the drug's impact. The trial will monitor participants closely to gather data on their health outcomes and response to the medication.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed HIV-1 infection who are treatment-naïve or have limited prior antiretroviral therapy.
Not a fit: Patients with active hepatitis B or C infections or those with a history of extensive drug use may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing HIV-1 infection in adults.
How similar studies have performed: Other studies have shown promise in evaluating new antiviral treatments for HIV, but the specific approach of STP0404 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a confirmed HIV-1 infection in the documented medical record or at screening. * Have never received any ARTs (i.e., treatment-naïve) before screening or only received one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. Participants with a documented history of PrEP and/or PEP therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion. * Have a CD4+ cell count ≥200 cells/mm3 at screening. Exclusion Criteria: * Have a hepatitis B surface antigen or positive hepatitis C virus antibody at screening. An HCV confirmation (HCV RNA test) will be performed at a central laboratory if the HCV antibodies screening result is positive. If the HCV RNA test result is negative, the participant will be eligible. * Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine. However, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decision shall rely on the investigator's medical judgment and should be documented. * Have a history of regular alcohol consumption, defined as an average weekly intake of \>14 drinks (males) or \>7 drinks (females), within 6 months of screening and/or has positive alcohol screen at screening and baseline. * Have received the following treatments as PrEP or PEP (≥1 dose) prior to screening: monoclonal antibodies, HIV-1 maturation inhibitors, and long-acting INSTIs (such as cabotegravir). * Pregnant or lactating females. * Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months. * Participant received any allosteric HIV-1 integrase inhibitor (ALLINI, ≥1 dose) and/or received any long-acting ARVs (marketed or investigational, ≥1 dose) prior to screening. * Have previously failed an INSTIs-containing regimen.
Where this trial is running
Los Angeles, California and 12 other locations
- Kaiser Permenente Los Angeles Medical Center — Los Angeles, California, United States (Recruiting)
- Ruane Clinical Research, Inc. — Los Angeles, California, United States (Recruiting)
- Midway Immunology and Research Center — Fort Pierce, Florida, United States (Recruiting)
- Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States (Recruiting)
- Orlando Immunology Center — Orlando, Florida, United States (Recruiting)
- USF Health South Tampa Center for Advanced Healthcare — Tampa, Florida, United States (Recruiting)
- Be Well Medical Center — Berkley, Michigan, United States (Recruiting)
- Saint Michael's Medical Center — Newark, New Jersey, United States (Recruiting)
- South Jersey Infectious Disease — Somers Point, New Jersey, United States (Recruiting)
- North Shore University Hospital — Manhasset, New York, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center - PPDS — Winston-Salem, North Carolina, United States (Recruiting)
- St Hope Foundation, Inc — Bellaire, Texas, United States (Recruiting)
- North Texas Infectious Diseases Consultants, P.A. — Dallas, Texas, United States (Completed)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.